Many surgical and medical procedures are sophisticated and/or complex procedures that require substantial and coordinated contributions from a number of different medical practitioners including physicians, nurses, technologists and other assistants.
In particular, many procedures require that teams of medical practitioners work together through an orchestrated sequence of steps to ensure that best practices for the delivery of a particular procedure is attained in accordance with a particular standard of patient care. For example, most surgical and medical procedures follow a logical sequence of steps that may involve any combination of assessment, diagnosis, imaging, preparation, procedure and follow-up.
Importantly, in many scenarios, while best practices may suggest that preferred procedures be followed, the particulars of an emergency medical condition may limit the ability of the medical team to complete the preferred steps either because of time constraints and/or the availability of equipment and/or tools to enable those steps.
For example, in the case of assessing and treating stroke patients suffering from cerebral arterial blockage, time to recanalization of cerebral arteries is a critical factor in patient outcome where the extent of brain damage may be significantly affected by the time taken to effect recanalization.
That is, any time saved during the procedures to assess, diagnose, image and treat a stroke patient may have significant effects on the status of the patient. While different steps in the process continue to be improved, for example, imaging and recanalization technologies continue to improve, other steps within the overall assessment and treatment protocols can be inefficient.
More specifically, the ability to achieve intra-arterial (IA) recanalization keeps getting better as demonstrated by studies (such as SWIFT, TREVO and others) and based on availability of newer devices such as Solitaire™, Penumbra™, or Trevo™. In most acute ischemic stroke patients, core (tissue which is already dead) expands into penumbra (tissue at risk of dying if reperfusion is not achieved emergently) over a period of time. While the ability to measure core is quite good, it is not perfect and the ability to measure how fast core is growing generally cannot be readily quantified. As such, it remains important to achieve recanalization as quickly as possible.
In a typical scenario, a patient having a stroke will go through the following sequence of steps. These will typically include recognizing symptoms, calling 911, and getting to the hospital and importantly the correct hospital. At the hospital, the patient will undergo clinical evaluation followed by imaging which will determine if the stroke is ischemic or hemorrhagic. If the stroke is ischemic, further imaging such as CTA (computer tomography angiography), CTP (computer tomography perfusion) and/or MRI (magnetic resonance imaging) may be undertaken. If there is large vessel proximal occlusion, a decision based on a number of factors will determine if the patient goes to a catheter lab (Cath-Lab) to attempt intra-arterial recanalization. Generally speaking Cath-Lab procedures are done for bad, potentially disabling strokes.
When the decision is made to initiate surgical treatment, a number of factors will come into play that must all be managed to enable treatment in what is a complex emergency situation. These factors include the time of day (may be after regular staffing hours), the assembly of different teams and the requirements for patient monitoring, anesthesia, consent and patient preparation for the procedure.
Due to the number of people involved as well as the surgical equipment involved, the setting up for the procedure is often confusing and time consuming. For example, there are at least 50 pieces of separate equipment that need to be opened from individual packets in order for a typical recanalization procedure to be initiated and each packet must be opened and/or prepared in a particular order. Catheters and other lines need to be flushed and attached to a pressure line in such a way that no air remains in the lines.
Further still, particularly when such procedures are being conducted as an emergency outside normal staffing hours, different members of the team may reach the lab at slightly different times. Depending on the time of arrival and the particular training of the team members, it may be difficult for certain team members to initiate the preparatory steps due to the lack of training to assemble and/or undertake such steps. Any delays in preparing the patient and/or the equipment will result in delays in initiating and completing the medical procedure itself. Moreover, medical teams do not want to be assembling or looking for equipment in the middle of the night when the procedure may be required. In addition, it may be desired that the procedure is performed at a hospital or treatment facility where the procedure is not routinely performed with the result being that a physician/medical team may not be familiar with the layout of an operating room and/or the storage locations of the equipment. As such, there is a need for equipment to be transportable in a convenient form so as to minimize time delays under these conditions.
In other words, there can be significant delays in the time from patient diagnosis to the commencement and completion of a recanalization procedure due to the time required to organize and deploy the surgical equipment.
Similarly, the same issues apply to the diagnosis and treatment of acute myocardial infarction patients. As with stroke patients, time is a critical factor in diagnosing and treating such patients. Also, the patient preparation and treatment procedures for recanalization and revascularization procedures are substantially similar in certain respects. That is, in undertaking treatment procedures in both acute stroke and myocardial infarction patients, catheter procedures are utilized to gain access to affected vessels and to effect treatment of those vessels by clot removal or coronary artery opening by balloon angioplasty and/or stenting.
A review of the prior art indicates that various surgical kits have been the subject of patent protection. However, the prior art does consider and does not teach or suggest a solution to the technical problem of more efficiently preparing for and undertaking an recanalization and revascularization procedures.
Examples of past surgical kits are discussed briefly below.
U.S. Pat. No. 7,288,090 describes an electrophysiological procedure kit containing the internal indifferent electrode device, a surgical probe and other tools or devices that may be required for a procedure.
U.S. Patent Application Publication No. 2011/0071572 describes a sterile single-use disposable orthopedic surgery kit for the internal fixation of fractured bones. The kit includes a single bone plate precontoured and sized to match the patient's anatomic shape. The kit includes a briefcase-like container that has partitions for compartmentalization, with all the components visible and accessible when the container is open.
U.S. Pat. No. 7,331,462 describes a kit management system for use in microsurgery that includes a plurality of tubing, surgical instruments, connectors, an instrument tray, a connector tray, and a tubing organizer. The tubing organizer secures and separates the tubing in a spaced relationship as needed during microsurgery.
U.S. Patent Application Publication No. 2003/0159969 and U.S. Pat. No. 7,401,703 describe a surgical kit including a tray having a plurality of planar surfaces with recesses for holding surgical implements. The planar surfaces are vertically offset from one another such that items in the top surface must be removed before items below can be accessed.
U.S. Pat. No. 4,501,363 describes a surgical kit having a pair of trays wherein one tray is received inside the other. Each tray includes a plurality of embossments in its bottom for receiving various surgical supplies. After the completion of the surgery, the inner tray is flipped over and set on top the outer tray to form a receptacle for post-operative materials.
U.S. Patent Application Publication No. 2011/0186456 describes a system of surgical instruments for knee surgery having various containers. Size-specific instruments are grouped in the containers according to size, such that once it is determined that a certain size of instruments are needed for a specific surgery, only the container(s) containing the necessary size of instruments needs to be opened.
U.S. Pat. No. 5,868,250 describes a tray for dispensing and receiving surgical equipment. The tray includes a bar for holding surgical instruments, particularly sharp instruments, that pivots upwardly into a raised position to allow the instruments to be easily removed from and returned to the bar. The bar may also be hollow to allow antiseptic solution to be pumped through it for sterilizing the instruments.
U.S. Patent Application Publication No. 2010/0274205 describes a wound treatment kit comprising three containers divided by the order of steps for treating a wound, specifically 1) preparation; 2) dressing; and 3) sealing.
U.S. Patent Application Publication No. 2002/0185406 and U.S. Pat. No. 7,100,771 describe a sterile pain management kit containing the primary medical supplies needed for performing a continuous nerve block procedure.
U.S. Pat. No. 8,240,468 describes a pre-packaged medical device including a tray for supporting the medical device, such as a blood collection set including a needle assembly and a tube holder.
U.S. Pat. No. 6,588,587 describes a packaging system for medical devices and surgical components used in heart by-pass surgery.
U.S. Pat. No. 6,412,639 describes a medical procedure kit containing surgical tools and medical adhesive. The medical adhesive may be independently sterilized and wrapped from the other surgical tools in the kit.
U.S. Pat. No. 4,523,679 describes a pre-sterilized medical procedure kit that contains a first unit pre-sterilized by ethylene oxide and a second unit containing a heat sterilized vial of medicament agent that is incompatible with ethylene oxide sterilization.
In view of the foregoing, there continues to be a need for systems and methodologies that address the foregoing problems with regards to IA recanalization and revascularization procedures and that specifically enable a medical team to reduce the total time that may be required to complete these procedures. In particular, there has been a need for systems and methodologies that permit members of a medical team to initiate the preparatory steps of a complex recanalization or revascularization procedure without requiring the assembly of the complete medical team. More specifically, there has been a need for modularized bundles of groups of recanalization or revascularization surgical equipment that enables different members of a surgical team to quickly and efficiently have access to equipment used in these procedures and where the layout of the modularized bundles logically corresponds to steps of the procedure.